Improving patient reassurance through an early intervention prior to exercise stress testing

ISRCTN	ISRCTN87589121
DOI	https://doi.org/10.1186/ISRCTN87589121
Protocol serial number	N/A
Sponsor	University of Auckland (New Zealand)
Funder	University of Auckland (New Zealand)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Keith Petrie
Scientific

Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
1001
New Zealand

Email	kj.petrie@auckland.ac.nz

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Providing information about normal findings prior to a exercise stress test will improve reassurance and reduce anxiety about symptoms following the investigation in patients with a negative test result.
Ethics approval(s)	Approved by New Zealand Ministry of Health Ethics Committee (ref AKY/04/05/121) on 21 May, 2004.
Health condition(s) or problem(s) studied	Symptoms of chest pain
Intervention	Group one: standard information. Group two: a pamphlet explaining the function and meaning of negative results from the test. Group three: the pamphlet and a brief discussion about what normal results of the test mean.
Intervention type	Other
Primary outcome measure(s)	1. Patients reported reassurance. 2. Levels of worry about their health and belief that something is seriously wrong with their heart, measured immediately following the test and at one month following testing.
Key secondary outcome measure(s)	Complaints of chest pain and whether continuing to take cardiac medication.
Completion date	31/10/2004

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	90
Key inclusion criteria	Patients referred for exercise stress test with negative findings
Key exclusion criteria	1. Aged less than 18 years 2. Previously diagnosed cardiac pathology 3. No symptoms of chest pain 4. Undertaking the stress exercise test as part of a pre-surgical medical examination 5. Positive exercise stress test
Date of first enrolment	01/06/2004
Date of final enrolment	31/10/2004

Department of Psychological Medicine

Auckland
1001
New Zealand

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	17/02/2007		Yes	No